U.S.-JAPAN WORKSHOP PROMOTES COLLABORATION TO

UNCLAS TOKYO 001589 SENSITIVE SIPDIS DEPT FOR EAP/J AND OES/IHB HHS PASS TO NIH/NCI HHS FOR OGHA DEPT PASS TO AID/GH/HIDN E.O. 12958: N/A TAGS: TBIO KSTH ECON PGOV SOCI CASC JA SUBJECT: U.S.-JAPAN WORKSHOP PROMOTES COLLABORATION TO IMPROVE LIVES OF CANCER PATIENTS ¶1. (SBU) Summary. Embassy Tokyo, the National Cancer Institute (NCI) and others hosted a workshop July 8 to promote better U.S.-Japan collaboration in cancer clinical trials. Nearly one hundred participants from academia, industry, government, and the media discussed how to strengthen capacities for clinical trials in Japan and how to develop partnerships between U.S. and Japanese researchers and institutions to improve the lives of cancer patients in both countries. Based on the results of the workshop and follow-on meetings with Japanese politicians and GOJ officials, Emboffs and NCI officials developed a list of action items to increase collaboration in clinical trials with Japan. The NCI representatives held a separate on-the-record briefing with Japanese media. End summary. ¶2. (SBU) Embassy Tokyo Economic Section, the Tokyo American Center, the U.S. National Cancer Institute (NCI),the Japan National Cancer Center, and the Academy of Cancer Experts joined forces to sponsor a daylong workshop to increase U.S.-Japan collaboration in cancer clinical trials. The workshop produced a frank dialogue on the need to expand the capacity for such clinical trials in Japan and the current obstacles to doing so. Attendees included senior officials of NCI's Cancer Therapy Evaluation Program, officials from the Ministry of Health, Labor, and Welfare (MHLW), representatives from the pharmaceutical industry, science journalists, and leading Japanese clinicians and researchers from a number of institutes and universities. ¶3. (SBU) Dr. Edward Trimble and Dr. Naoko Takebe of NCI explained the U.S. model for clinical trials and outlined the benefits of international collaboration in such trials. The benefits noted include: 1) larger samples that lead to improved treatments; 2) the ability to identify patients with particular genetic characteristics and thus to design targeted therapy techniques; 3) the promotion of widespread international adoption of new drugs and research findings; and 4) the promotion of investigator-initiated trials of drugs for rare types of cancer that pharmaceutical companies might not otherwise sponsor. ¶4. (SBU) Workshop participants pointed out the following impediments to effective clinical trials in Japan: 1) slow approval for new drugs; 2) lack of trial facilities and trained investigators; 3) overburdened medical staff; 4) high cost of drug trials; 5) poor communication between research institutions and industry; 6) resistance to clinical trials by some patients and patient groups; 7) a national health insurance system that does not support mixed treatment schemes; and 8) a hierarchical doctor-patient relationship in which physicians often lack interest in patient-oriented research. (Note. Japan has long lagged behind other advanced industrialized countries in the number of clinical drug trials. However, in 2007 MHLW pledged to reduce the time needed for new drug approvals by 2011, in part by supporting the efficient implementation of global clinical trials. End note.) ¶5. (SBU) Dr. Trimble and Dr. Takebe reported coming away from the workshop and follow-on meetings with MHLW, the Cabinet Office, and Diet members with a much stronger understanding of the Japanese institutional and regulatory framework governing clinical trials. Action items from the meetings and workshop include expanding collaboration between NCI and Japanese pharmaceutical companies on drug development, initiating collaboration between NCI and Japanese research centers in preclinical and early phase clinical evaluation of new cancer drugs, expanding collaboration between NCI and Tokyo University's Riken Institute in pharmacogenomic studies, and initiating possible personnel and information exchanges between Japanese and American cancer and patient advocacy groups. ¶6. (SBU) In addition to the workshop, Dr. Trimble and Dr. Takebe held an on-the-record press briefing attended by eight journalists, including representatives of major public broadcaster NHK and widest-circulation daily Yomiuri Shimbun. POST